Senior Director, Regulatory Affairs

Merck; North Wales (Montgomery County); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck seeks a Senior Director to lead a team of promotional regulatory professionals in the U.S. regulatory review of promotional materials for assigned products.

The role requires strategic regulatory leadership across multiple therapeutic franchises, ensuring alignment with FDA regulations and corporate policies, while managing escalations with senior leadership. The position emphasizes collaboration with commercial, legal, medical, and external stakeholders (FDA OPDP/APLB) to optimize

Qualifications

• Minimum 12 years’ experience in pharmaceutical/biologics regulatory, clinical, medical, legal, and/or marketing disciplines, including advertising/promotional review work
• Minimum 6 years’ experience reviewing advertising and promotion materials or marketing programs for regulatory/legal compliance
• Expert understanding of FDA regulations and company policies related to promotion development and review processes
• Expert understanding of the clinical development process, including labeling development and FDA approval processes
• Proven ability to lead and direct complex activities of a team and drive cross-functional work

Responsibilities

• Leads a team of promotional regulatory reviewers to provide regulatory strategy across multiple therapeutic franchises for pipeline and in-line products
• Partners with commercial and other stakeholders to develop a promotional regulatory strategy aligned with regulations
• Serves as critical leadership point of contact for assigned brands and escalations
• Oversees direct report’s product assignments and ensures integrated regulatory strategy from development through marketing
• Demonstrates ability to influence external stakeholders including FDA and cross-divisional teams

Skills

Regulatory leadership

FDA regulations

Strategic planning

Cross-functional collaboration

Communication skills

Team leadership

Promotional review

Regulatory strategy

Education

Bachelor degree (science-related)

Job description

Job Description

The Senior Director manages a team of promotional regulatory professionals in the regulatory review of U.S. promotional materials for assigned products.

The Senior Director manages a team of promotional regulatory professionals in the regulatory review of U.S. promotional materials for assigned products.

Summary Of Responsibilities

• Leads a team of promotional regulatory reviewers (senior specialists, associate directors, and individual contributor directors) to provide regulatory strategy across multiple therapeutic franchises for pipeline and in-line products that competitively positions our company's products, consistent with applicable FDA regulations and company policies for US advertising and promotion. Ensures strategy is aligned with overall corporate strategy and organizational goals. The senior director will be responsible for providing a regulatory risk assessment and managing escalations with senior leaders.
• Partners with commercial and other stakeholders to develop a promotional regulatory strategy and product positioning that aligns commercial strategy with regulations. Drives optimal regulatory strategy, planning and delivery for advertising and promotion to support the overall business goals for therapeutic area(s) of focus. Serves as critical leadership point of contact for assigned brands and associated escalations, as needed.
• Serves as critical partner with HH, Legal and Medical on cross-divisional transformation work inclusive of process redesign and technology enablement.
• Oversees direct report’s product assignments and ensures collaboration and a cohesive and integrated regulatory strategy from early development through approval and marketing. Provides guidance and coaching to direct reports on their input to product labeling, global regulatory team strategy, adequate support of promotional messaging and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion. Ensures direct reports are compliant with corporate policies and complete all required corporate and compliance training.
• Demonstrated ability to impact and drive regulatory decisions with senior company leadership and with FDA. Helps shape regulatory policy with OPDP and APLB on emerging topics and innovative technologies. Serves on external promotional regulatory planning committees and contributes to our company's regulatory leadership by presenting at leading external regulatory meetings (DIA, FDLI, RAPS etc.).
• Identifies the need for development, refinement, and implementation of department and corporate strategic initiatives that drive effective, compliant promotional regulatory review.
• Analyzes business needs and capacity and contributes to staffing discussions with Executive Director.
• Serves as a liaison with OPDP and/or APLB Team Leaders or reviewers for business-critical initiatives.
• Effectively interprets and communicates FDA perspectives to relevant company stakeholders and recommends policy and/or process changes as needed.

Education Minimum Requirement

• Bachelor of Arts or Science Degree, with advanced degree preferred. Strongly preferred to have a science-related degree such as biology, chemistry, nursing, pharmacy, social sciences, or QA/regulatory affairs.

Required Experience And Skills

• Minimum 12 years’ experience in pharmaceutical/biologics regulatory, clinical, medical, legal, and or marketing disciplines, including demonstrated advertising/promotional review work
• Minimum 6 years’ experience reviewing advertising and promotion materials or marketing programs for regulatory/legal compliance
• Expert understanding and application of FDA regulations and our company's policies and procedures related to promotion development and implementation and promotion review processes
• Expert understanding of the clinical development process, including labeling development and FDA approval processes
• Demonstrated ability to lead and direct complex activities of a Team and drive work effectively in a cross-functional team environment
• Collaborative – ability to build deep relationships cross-functionally to drive optimal performance
• Demonstrated superior verbal and written communication skills
• Strong interpersonal and negotiation skills with ability to demonstrate strategic and analytic thinking
• Demonstrated ability to negotiate and influence others effectively
• Proven track record of effective collaboration with external stakeholders which may include FDA branches (OPDP, APLB), alliance relationships with peer companies as well as external consortia and trade organizations such as DIA. Strong judgment and decision-making skills.

Required Skills

Business Alignment, Cross-Functional Project Management, Decision Making, Global Regulatory Submissions, Goal Setting, Interpersonal Relationships, Negotiation, People Leadership, Policy Reviews, Policy Revisions, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Management, Regulatory Processes, Regulatory Reporting, Regulatory Strategies, Regulatory Submissions, Stakeholder Negotiations, Strategic Planning, Strategic Thinking

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The salary range for this role is

$173,200.00 - $272,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.